Poster Topical Area: Methods and Protocols

Location: Hall D

Poster Board Number: 685

P15-024 - Defining functional benefits and safety of universal multiple micronutrient powders and iron supplements to young children – the BRISC and IRMA randomised controlled trials

Monday, Jun 11
8:00 AM – 3:00 PM

Objectives: Anaemia affects ~43% of pre-school children globally, with most of this burden in low income countries. WHO recommends universal iron-containing Multiple Micronutrient Powders (MNPs) or iron supplements to children in areas where anaemia is prevalent. Reasons for giving iron include possible benefits on child development and wellbeing: however, recent meta-analyses of randomized controlled trials (RCTs) in children 6-23 months found negligible evidence that iron interventions benefit these outcomes. Conversely, iron may promote infection. Universal iron in malaria-endemic areas is only recommended where co-interventions to address malaria are provided: however, these co-interventions are not defined.



Methods: To resolve these evidence gaps, we have launched two large randomised, blinded, double dummy placebo controlled trials. Benefits and Risks of Iron interventions in Children (BRISC)is set in Bangladesh, and is randomising 3300 children aged 8 months to a) iron syrup (12.5mg elemental iron) + placebo MNPs, b) MNPs (12.5mg elemental iron) + placebo syrup, and c) placebo syrup + placebo MNPs, for 3 months, with follow up for a further 9 months. IRon with MAlaria chemoprevention (IRMA) will be a 3-arm trial in 1590 6-month old children in rural and semi-urban Malawi comparing a) MNPs+Dihydroartemisinin-Piperaquine (DP - a long-acting antimalarial for malaria chemoprevention), b) DP + MNP placebo, and c) DP placebo/ MNP placebo, for a 6-month intervention period, and follow-up for 6 months. In both trials, the primary outcome is cognitive development (Bayley Scales) at end of intervention and post-follow up. Secondary outcomes include behaviour, growth, incidence of infection, parasitaemia (IRMA), and haemoglobin and ferritin.




Results:
BRISC has recruited >800 children (to 18th Jan), and will close for recruitment in early 2019. Results should be available in late 2020. IRMA will open in late 2018, with results available in 2022.




Conclusions:
These pivotal studies will provide evidence for the functional effects of universal iron interventions on child health, will indicate differential effectiveness and safety between MNPs and iron supplements, and determine if malaria prevention makes iron interventions safe. The data should guide nutrition policies.



Funding Source: National Health and Medical Research Council, Australia
Trial Designs for BRISC and IRMA

CoAuthors: Mohammed Imrul Hasan – icddr,b; Sheikh Jamal Hossain – icddr,b; Sabine Braat – University of Melbourne; Fahmida Tofail – icddr,b; Kamija Phiri – College Of Medicine, University of Malawi; Jena Hemadani – icddr,b; Beverley-Ann Biggs – University of Melbourne

Sant-Rayn Pasricha

Lab Head
Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria, Australia